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DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN - Generic Drug Details

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What are the generic drug sources for dextromethorphan hydrobromide; guaifenesin and what is the scope of patent protection?

Dextromethorphan hydrobromide; guaifenesin is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma Ltd, Perrigo R And D, and Rb Hlth, and is included in five NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dextromethorphan hydrobromide; guaifenesin has thirty-nine patent family members in nineteen countries.

There are twenty-three drug master file entries for dextromethorphan hydrobromide; guaifenesin. Fifty-three suppliers are listed for this compound.

Summary for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

International Patents:	39
US Patents:	3
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	23
Suppliers / Packagers:	53
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
DailyMed Link:	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN at DailyMed

Paragraph IV (Patent) Challenges for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
MUCINEX DM	TABLET, EXTENDED RELEASE;ORAL	dextromethorphan hydrobromide; guaifenesin	021620	2008-12-17

US Patents and Regulatory Information for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	209692-002	Nov 1, 2018		OTC	No	No
Perrigo R And D	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	207602-002	Mar 5, 2018		OTC	No	No
Actavis Labs Fl	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	091070-001	Aug 31, 2015		OTC	No	No
Perrigo R And D	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	207602-001	Mar 5, 2018		OTC	No	No
Aurobindo Pharma Ltd	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	206941-001	Mar 17, 2017		OTC	No	No

Expired US Patents for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004

International Patents for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Country	Patent Number	Estimated Expiration
Japan	5466346
Taiwan	200733952
Taiwan	200400836
Eurasian Patent Organization	007156
Japan	2003531849

Supplementary Protection Certificates for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	13C0062	France		PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
1539166	122013000090	Germany		PRODUCT NAME: KOMBINATION AUS: (A) DEXTROMETHORPHAN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ, Z.B. DEXTROMETHORPHAN-HYDROBROMID UND INSBESONDERE DEXTROMETHORPHAN-HYDROBROMID-MONOHYDRAT; UND (B) CHINIDIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, Z.B.CHINIDIN-SULFAT UND INSBESONDERE CHINIDIN-SULFAT-DIHYDRAT; REGISTRATION NO/DATE: EU/1/13/833 20130624
1539166	CR 2013 00059	Denmark		PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1539166	2013C/064	Belgium		PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626
1539166	2013/055	Ireland		PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624